Trial Outcomes & Findings for Cognitive Training With and Without tDCS to Improve Cognition in HIV (NCT NCT02647645)
NCT ID: NCT02647645
Last Updated: 2021-06-22
Results Overview
Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates.
TERMINATED
NA
21 participants
3 weeks
2021-06-22
Participant Flow
Participant milestones
| Measure |
Cognitive Training
Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Cognitive Training With tDCS
Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Cognitive Training
Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Cognitive Training With tDCS
Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Cognitive Training With and Without tDCS to Improve Cognition in HIV
Baseline characteristics by cohort
| Measure |
Cognitive Training
n=11 Participants
Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Cognitive Training With tDCS
n=10 Participants
Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.45 years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
48.70 years
STANDARD_DEVIATION 7.04 • n=7 Participants
|
47.52 years
STANDARD_DEVIATION 8.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: All participants who completed treatment.
Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates.
Outcome measures
| Measure |
Cognitive Training
n=9 Participants
Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Cognitive Training With tDCS
n=9 Participants
Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation
|
|---|---|---|
|
Working Memory: Participants' Rate of Improvement
|
6.61 units on a scale
Standard Error 0.62
|
7.45 units on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: All participants who completed the study.
Participants' mood over the course of the study. We used the Center for Epidemiological Studies--Depression scale (CES-D) to measure mood. This measure includes 20 items that ask the person assessed to report his or her experience of mood symptoms over the past two weeks. Participants completed this measure before and after the study intervention. Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse as they indicate more frequent or more severe mood symptoms.
Outcome measures
| Measure |
Cognitive Training
n=9 Participants
Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Cognitive Training With tDCS
n=9 Participants
Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation
|
|---|---|---|
|
Center for Epidemiological Studies Depression Scale (CES-D)
|
12.95 units on a scale
Standard Error 6.21
|
23.37 units on a scale
Standard Error 5.10
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: All participants who completed training.
Patient report of cognitive difficulties on the Patient Assessment of Own Functioning. This scale comprises 33 items describing problems in thinking, language, and memory. Participants rate each items according to how often they experience each problem on a six-point scale from "almost never" (score of 0) to "almost always" (score of 5). The participant's score is the sum of ratings on all items. The range of possible scores on each item is from 0 to 5, with most persons achieving a score of 1.5 or lower. Higher scores represent more frequent report of cognitive difficulties and thus are considered worse. The range of all possible scores for the full scale of 33 items is is 0 to 165.
Outcome measures
| Measure |
Cognitive Training
n=9 Participants
Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation
|
Cognitive Training With tDCS
n=9 Participants
Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation
|
|---|---|---|
|
Patient's Own Assessment of Function (PAOF)
|
7.39 Score on a scale
Standard Error 0.73
|
9.17 Score on a scale
Standard Error 0.73
|
Adverse Events
Cognitive Training
Cognitive Training With tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place